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Regulatory Affairs and QA Coordinator

1 week ago

Sydney, New South Wales, Australia Venues NSW Full time
About Our Company
Kardium Inc. is a pioneering medical device company that has developed a groundbreaking technology for the diagnosis and treatment of atrial fibrillation. Our mission is to deliver innovative solutions that improve patient outcomes, and we are committed to excellence in all aspects of our business.

Job Description
We are seeking a highly skilled Quality Assurance (QA) Specialist to join our team. As a member of our QA Team, you will play a critical role in ensuring the quality and integrity of our products, and contributing to the continuous improvement and maintenance of our Quality Management System (QMS).

Key Responsibilities
Your key responsibilities will include:
  • Conducting QA reviews of production documentation, including Device Master Records and Device History Records.
  • Providing QA support to our Manufacturing and Engineering teams, including reviewing verification and validation documentation and providing input into process validation activities.
  • Developing and implementing quality improvement initiatives to enhance our QMS.

Requirements
To be considered for this role, you will need to possess the following qualifications:
  • A bachelor's degree in a technical discipline, such as engineering or pharmaceutical sciences.
  • At least 3 years' experience in QA in a manufacturing environment in the biotechnology industry, with a strong working knowledge of ISO 13485 and FDA QSR requirements.
  • Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.

What We Offer
Kardium offers a comprehensive benefits package, including health and dental coverage, life insurance, and retirement savings plan contributions. We also offer opportunities for career growth and professional development, as well as a dynamic and supportive work environment.